GBM Brain Cancer Sorting Development Latest Bit of Good News for Patients as CNS Pharmaceuticals (NASDAQ: CNSP) Develops Drug Trial

• Biopharmaceutical developer CNS Pharmaceuticals is working on ways to improve overall survivability for glioblastoma multiforme (“GBM”) brain cancer patients
• GBM is considered to be an incurable brain cancer that usually only leaves patients about 15 months to live once they are diagnosed, prompting research efforts to improve patients’ responses to therapeutic approaches
• A recent study found that the GBM patients most likely to succumb within a relatively short period could be identified with non-invasive MRI scans, allowing researchers to grant them priority in clinical trials
• Another recent study found patient responses could be improved simply by changing the time of day that therapy is administered to the morning
• CNS Pharmaceuticals’ lead drug candidate, Berubicin, showed promise in a small Phase 1 trial 15 years ago and now is being prepped for a larger Phase 2 trial
• Two other clinical trials are in development by sublicensee partner WPD Pharmaceuticals in Europe, including one for pediatric patients with malignant gliomas

Researchers’ recent successful efforts to identify a select set of brain cancer patients least likely to prolong survival when receiving standard treatment have been welcomed by the medical community amid efforts to develop better treatments and potential cures.

The announcement by the Cimino lab at The University of Washington and Seattle’s Fred Hutchinson Cancer Research Center last month states a machine learning model has been developed that is “capable of identifying glioblastoma (‘GBM’) patients predisposed to poor survival from non-invasive MRI scans alone,” thus providing a simple means of routing the most needing patients to priority positions in clinical trials “because they are the patients whose first-line therapy is most likely to fail” (https://ibn.fm/NZgN1).

The news follows on an announcement by Washington University School of Medicine in St. Louis that GBM patients may gain longer survival rates simply by changing what time of day they receive treatments (https://ibn.fm/YokbN).

CNS Pharmaceuticals (NASDAQ: CNSP) is one of the companies working to produce a treatment that improves on the effectiveness of established chemotherapy drug lomustine in increasing overall survival rates of GBM patients. GBM is an illness that is nearly 100 percent fatal in patients just over a year after it’s diagnosed, and CNS Pharmaceuticals’ lead drug candidate, Berubicin (https://ibn.fm/up2fu), has been granted investigational new drug (“IND”) status after promising findings that Berubicin may generate better patient outcomes.

Berubicin is a stand-out anthracycline therapy because of its novel apparent ability to cross the blood-brain barrier to combat neurological tumors. The drug was the subject of a Phase I trial some 15 years ago in which 44 percent of patients saw their disease stabilize or improve and one patient achieved cancer-free status that has resulted in length of survival currently far beyond standard expectations, with the most recent evaluation conducted in November of 2020.

CNS recently announced it is beginning to enroll patients for its planned Phase 2 trial so the first patient is likely to be dosed in the near term. The Phase 2 trial will compare Berubicin’s response to the effectiveness of lomustine in 243 GBM patients at about 35 clinical sites in the United States (https://ibn.fm/3EjRq) and an additional 25 sites across Europe and Asia Pacific.

The company’s timeline includes a similar Phase 2 clinical trial of Berubicin in Poland during the present quarter conducted by CNS’s sublicensee partner, WPD Pharmaceuticals. WPD is also preparing to start a clinical trial to determine Berubicin’s safe use in pediatric patients with malignant gliomas later in the year, which would be the first investigation of Berubicin for children with these brain cancers (https://ibn.fm/Z1Wu0).

CNS’s recent update to its annual 10K filing with the U.S. Securities and Exchange Commission (“SEC”) notes that WPD’s sublicense requires it to use reasonable efforts to develop and commercialize the companies’ products in the European countries Poland, Estonia, Latvia, Lithuania, Belarus, Ukraine, Moldova, Romania, Bulgaria, Serbia, Macedonia, Albania, Armenia, Azerbaijan, Georgia, Montenegro, Bosnia, Croatia, Slovenia, Slovakia, Czech Republic, Hungary, Chechnya, Uzbekistan, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Greece, Austria, and Russia (https://ibn.fm/OkVHf).

“We expect, in the next 90 to 120 days, we will go from zero active clinical trials today to three active clinical trials,” CNS CEO John Climaco said in a January podcast interview. “We have five employees at this company, so we are a tiny little shop. But we have an absolute powerhouse compound” (https://ibn.fm/mzvWd).

For more information, visit the company’s website at www.CNSPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at https://ibn.fm/CNSP

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